Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2015-08-26FDA-DrugMylan Institutional LLCClass ICARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-493-46, UPC 3 67457 49346 6.
Presence of Particulate Matter
- 2015-08-26FDA-DrugGC Natural Nutrition, Inc.Class IPYROLA Advanced Joint Formula capsules, 60-count bottle, G & C Natural Nutrition Inc., Fullerton, CA 92833, UPC 7 11746 00075 8.
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and chlorpheniramine, an over-the-counter antihistimine, making this an unapproved drug.
- 2015-08-19FDA-DrugMylan Institutional LLCClass ICytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0152-02), Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017.
Presence of Particulate Matter
- 2015-08-19FDA-DrugMylan Institutional LLCClass IMethotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-0146-01; and b) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-467-99.
Presence of Particulate Matter
- 2015-08-19FDA-DrugFresenius Kabi USA, LLCClass IIIHydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
- 2015-08-19FDA-DrugBaxter Healthcare Corp.Class II0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0049-03.
Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.
- 2015-08-19FDA-DrugDr. Reddy's Laboratories, Inc.Class IIRivastigmine Tartrate Capsules, USP 1.5 mg, 60 count bottle, Rx Only, Mfd. By Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-352-60
Failed Dissolution Specifications
- 2015-08-19FDA-DrugGlaxoSmithkline Consmer HealthcareClass IISENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01); b) 3.4 oz. (96.4 g) tubes, (NDC 0135-0548-02) Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
- 2015-08-19FDA-DrugGlaxoSmithkline Consmer HealthcareClass IISENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0547-02
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
- 2015-08-19FDA-DrugGlaxoSmithkline Consmer HealthcareClass IISENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0573-02
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
- 2015-08-19FDA-DrugGlaxoSmithkline Consmer HealthcareClass IISENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0572-02
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
- 2015-08-19FDA-DrugGlaxoSmithkline Consmer HealthcareClass IIbiotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
- 2015-08-19FDA-DrugGlaxoSmithkline Consmer HealthcareClass IIbiotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
- 2015-08-19FDA-DrugGlaxoSmithkline Consmer HealthcareClass IIbiotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g) tubes., (NDC 0135-0557-02) , b) 0.75 oz. (21.3 g) tubes, (NDC 0135-0487-02), c) 4.3 oz. (121.9 g) tubes, (NDC 0135-0557-01), d) 4.5 oz. (127.6 g) tubes, (NDC 0135-0487-01), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
- 2015-08-19FDA-DrugGlaxoSmithkline Consmer HealthcareClass IIbiotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
- 2015-08-12FDA-DrugThe Apothecary Shoppe LLCClass IIS-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
- 2015-08-12FDA-DrugThe Apothecary Shoppe LLCClass IISIH-Hydroxyprogesterone Caproate 250, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
- 2015-08-12FDA-DrugThe Apothecary Shoppe LLCClass IISIU-Phentolamine 5 mg/mL in Normal Saline, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
- 2015-08-12FDA-DrugThe Apothecary Shoppe LLCClass IISIU-Prostaglandin E1 500 mcg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
- 2015-08-12FDA-DrugThe Apothecary Shoppe LLCClass IISO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
- 2015-08-12FDA-DrugThe Apothecary Shoppe LLCClass IISIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135,NDC 99999-2011-17
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
- 2015-08-12FDA-DrugThe Apothecary Shoppe LLCClass IISIU-Tri-Mix 24 mg/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13389-1152-36
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
- 2015-08-12FDA-DrugThe Apothecary Shoppe LLCClass IISIU-Tri-Mix 30/2/20 Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1398-47
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
- 2015-08-12FDA-DrugThe Apothecary Shoppe LLCClass IISIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-2196-10
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
- 2015-08-12FDA-DrugThe Apothecary Shoppe LLCClass IISIU-Tri-Mix 24/1/20 Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1747-39
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
- 2015-08-12FDA-DrugThe Apothecary Shoppe LLCClass IISIU-Tri-Mix 20/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2913-85
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
- 2015-08-12FDA-DrugThe Apothecary Shoppe LLCClass IISIU-Tri-Mix 18/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-1540-18
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
- 2015-08-12FDA-DrugThe Apothecary Shoppe LLCClass IISIU-Tri-Mix 6/0.33/3.33 Injection Solution, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2007-70
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
- 2015-08-12FDA-DrugThe Apothecary Shoppe LLCClass IISIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1563-48
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
- 2015-08-12FDA-DrugThe Apothecary Shoppe LLCClass IISIU-Tri-Mix 17/0.6/5.7 Injectable, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2348-22
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
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